Multipro Catheter

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K841797 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Stockert-Shiley Caps Venous Occlusion Clamp

  Class I

  FDA 510(k) K864890 Active Cleared 19 Feb 1987

• Basic Heater-Cooler Unit, 115/100V 16-02-20

  Class II

  FDA 510(k) K883330 Active Cleared 26 Sep 1988

• Schneider-Shiley Y-Connector with Rotator

  Class II

  FDA 510(k) K862464 Active Cleared 28 Aug 1986

• Expanded Use for Shiley 3l Cardiotomy Reservoir

  Class II

  FDA 510(k) K872721 Active Cleared 23 Sep 1987

• Shiley Venous Reservoir

  Class II

  FDA 510(k) K854841 Active Cleared 10 Feb 1986

• Arterial Embolectomy Catheter

  Class II

  FDA 510(k) K840198 Active Cleared 3 Aug 1984

See all devices from Shiley, Inc. →

• What is the Multipro Catheter used for?

  The Multipro Catheter is a percutaneous catheter designed for vascular access procedures, as indicated by its classification under product code DQY and review by the Cardiovascular advisory committee, which evaluates devices intended for use in the circulatory system.

• How was the Multipro Catheter cleared for market?

  The device received FDA clearance through the traditional 510(k) pathway on August 10, 1984, after Shiley, Inc. demonstrated it was substantially equivalent to a legally marketed predicate device, as documented in clearance K841797.

• What class and regulatory pathway applies to the Multipro Catheter?

  The Multipro Catheter is classified as a Class II medical device under FDA regulations, which means it is subject to special controls, and it obtained market authorization via the 510(k) submission process, not requiring premarket approval.